Effect of 12-month daily resveratrol supplementation on brain health in post-menopausal women (Supporting healthy ageing in women with resveratrol - RESHAW)
Effect of 12-month daily resveratrol supplementation on brain health in post-menopausal women
University of Newcastle
170 participants
Nov 18, 2016
Interventional
Conditions
Summary
The decline in estrogen production at menopause heightens a woman’s risk of osteoporosis, heart disease, hypertension, stroke and dementia. We have now identified postmenopausal women as another vulnerable population at risk of dementia who may also benefit from resveratrol supplementation – a strategy that can be easily incorporated into the daily diet. We aim to gather evidence for the efficacy of vasoactive nutrients in maintaining optimal circulatory function to reduce the risk of developing dementia. Given that resveratrol supplements are available over-the-counter to consumers in Australia, the anticipated outcomes will offer a non-pharmaceutical approach for managing menopause-related symptoms and counteracting accelerated cognitive and physical decline and loss of bone mineral density in women post-menopausally, which can be readily implemented by clinicians and the public. We will recruit 170 post-menopausal women aged between 45 and 85 years old. A 24 month randomised, double-blind, placebo-controlled, crossover dietary intervention trial will be conducted at the University of Newcastle. A crossover intervention means that all participants will receive the resveratrol treatment. The primary objective of the study is to determine in postmenopausal women the ability of resveratrol supplementation for 12 months to improve cognitive function. The secondary objectives are: To determine whether improvements in cognition, mood, overall well-being (sleep quality, menopausal symptoms and pain) and physical function are accompanied by improvements in cerebrovascular responsiveness to cognitive demands, photic stimulation and/or to hypercapnia. To determine whether resveratrol supplementation can attenuate global cognitive decline. To determine whether resveratrol supplementation can change body bone mineral density and body composition. To determine the effects of resveratrol supplementation on clinic blood pressure and arterial compliance. To determine whether the improvements in the outcomes are related to changes in biomarkers of cardiovascular and bone health, hormone levels and plasma resveratrol concentration.
Eligibility
Inclusion Criteria1
- Women aged 45-85 years old. Post-menopausal (cessation of menses for > 12 months), with no change in medication type or dose for 3 months before the intervention.
Exclusion Criteria20
- Consuming HRT or seeking alternative therapy for the relief of postmenopausal symptoms (within the past three months).
- Pregnant or breastfeeding.
- Clinic BP >160mmHg systolic or 100mmHg diastolic (determined at screening).
- BMI>40kg/m2 (determined at screening).
- Dementia.
- History of breast or cervical cancer, mastectomy or hysterectomy (not due to prolapse).
- Smokers or currently on nicotine therapy.
- Neurological conditions.
- Kidney/liver disease.
- Insulin therapy.
- Warfarin therapy.
- Regularly consuming more than four standard alcoholic drinks per day.
- Major depression as diagnosed by a health care professional.
- Illiterate.
- Physical difficulty that will impede motor and locomotive performance.
- Unable to walk without assistance from people (walking aids okay).
- Unwilling to maintain pre-enrolment physical activity levels and dietary habits for the duration of the trial.
- Unwilling to refrain from consuming stimulants before each clinic visit.
- Currently consuming resveratrol containing supplements.
- Have any other medical condition or treatments (including supplements) which, in the investigators’ opinion, may confound the outcome of the study.
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Interventions
A 12 month randomised, double-blind, placebo-controlled, crossover dietary intervention trial. The active group will receive a 150mg dose of eveResveratrol Trademark (taken as two 75mg capsules) per day. The control group will receive a placebo. At the end of visit 5, at 12 months, participants will crossover to the alternate treatment arm for another 12 months. There is no washout period between treatments. At each visit following the dispensing of the supplement, participants will return their supplement bottle and supplement diary to check compliance.
Locations(1)
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ACTRN12616000679482